FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (2009)

 
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ACKNOWLEDGEMENTS

EXECUTIVE SUMMARY   

CONTENTS

ACKNOWLEDGEMENTS

The following individuals and/or entities are to be recognized for their invaluable contributions to the development of this report and the implementation of this project:

FDA:

Center for Food Safety and Applied Nutrition (CFSAN)

• Marc Boyer, Biostatistics Branch
• Martine Ferguson, Biostatistics Branch
• Jerome Schneidman, Biostatistics Branch

Office of Information Management

• Jack Jentai Su, IT Specialist

Office of Regulatory Affairs (ORA)

• Regional State Cooperative Program Directors
• Regional Retail Food Specialists
• Richard Barnes, Division of Federal-State Relations (DFSR)

National Retail Food Steering Committee

• Kevin Smith, CFSAN, Director – Retail Food and Cooperative Programs, Coordination Staff, Committee Chair
• Elizabeth O’Malley, Director of Cooperative Programs – Northeast Region, Field Team Representative
• Glenda Lewis, CFSAN, OC/DCP/Retail Food Protection Team (RFPT) –Team Leader, Team Representative
• Shirley Bohm, CFSAN, OC/DCP/RFPT, Team Representative
• Kathryn Kennedy, ORA, Regional Retail Food Specialist, Field Team Representative
• Steve Nattrass, ORA, Regional Retail Food Specialist, Field Team Representative
• Jim Fear, ORA, Manager State Training Team, Division of Human Resource Development (DHRD), DHRD Team Representative

OTHER REGULATORY:
State and local regulatory jurisdiction representatives who accompanied the FDA Regional Retail Food Specialists on data collection inspections.

INDUSTRY:
Industry food service managers of selected participant establishments for their cooperation and assistance during the data collection.

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EXECUTIVE SUMMARY

In 2008, the U.S. Food and Drug Administration’s (FDA) National Retail Food Team conducted the third phase of a three-phase,10-year study to measure the occurrence of practices and behaviors commonly identified by the Centers for Disease Control and Prevention (CDC) as contributing factors in foodborne illness outbreaks. Specifically, the study called for conducting data collection inspections of various types of foodservice and retail food establishments at five-year intervals to observe and document practices and behaviors that relate to the following CDC contributing factor categories associated with foodborne illness outbreaks within foodservice and retail food establishments, herein referred to as foodborne illness risk factors (risk factors):

• Food from Unsafe Sources
• Poor Personal Hygiene
• Inadequate Cooking
• Improper Holding/Time and Temperature
• Contaminated Equipment/Protection from Contamination

This 2009 report is the third report in a series and presents findings based on data collected in 2008.  The first report in the study was issued in August 2000 and presented the findings from the first data collection effort in 1998. A second report was issued in 2004 and presented data collected in 2003. FDA intends to publish a report in 2010 that compares the results from the three data collection periods and examines what trends, if any, were observed.  

The 2000 and 2004 reports called attention to the need for greater active managerial control of foodborne illness risk factors. They suggested that more innovative and effective strategies to improve food safety practices in retail and foodservice establishments were needed. The reports highlighted operational areas most in need of improvement including employee handwashing, cold holding of potentially hazardous foods (time/temperature control for safety foods), date marking of ready-to-eat foods, and cleaning and sanitizing of food contact surfaces.

In each phase of the study, FDA Regional Retail Food Specialists collected data during site visits of over 800 establishments representing nine distinct facility types. Direct observations, supplemented with information gained from discussions with management and food employees, were used to document the establishments’ compliance status for 42 individual data items based on provisions in the 1997 FDA Food Code. In each establishment, the compliance status for each data item was recorded in terms of IN Compliance, Out of Compliance, Not Observed (meaning the behavior or practice was applicable but not observed during the visit), or Not Applicable (meaning the behavior or practice did not apply to the establishment). 

For each of the nine facility types, the percentage of observations recorded as Out of Compliance is presented for each risk factor and for the individual data items related to those risk factors most in need of priority attention. The percent Out of Compliance value for each risk factor was calculated by dividing the total number of Out of Compliance observations of data items in the risk factor by the total number of observations (IN compliance and Out of Compliance) of data items in the risk factor. The percent Out of Compliance values for individual data items were calculated by dividing the total number of Out of Compliance observations for the individual data item by the total number of observations (IN and Out of Compliance) for the data item. 

The data presented in this 2009 report indicate that some of the same risk factors and data items identified as problem areas in the 2000 and 2004 Reports remain in need of priority attention.  This indicates that industry and regulatory efforts to promote active managerial control of these risk factors must be enhanced. The Out of Compliance percentages remained high for data items related to the following risk factors:

• Improper Holding/Time and Temperature
• Poor Personal Hygiene
• Contaminated Equipment/Protection from Contamination

For the improper holding/time and temperature risk factor, the high percent Out of Compliance values were most commonly associated with improper cold holding of potentially hazardous food (PHF)/time-temperature control for safety (TCS) food and inadequate date marking of refrigerated, ready-to-eat PHF/TCS Food.

Within the poor personal hygiene risk factor, the proper, adequate handwashing data item had the highest percent Out of Compliance value for every facility type. Percent Out of Compliance values for proper, adequate handwashing ranged from approximately 18% for meat departments to approximately 76% for full service restaurants. 

Of the data items related to the contaminated equipment/protection from contamination risk factor, improper cleaning and sanitizing of food-contact surfaces before use was the item most commonly observed to be Out of Compliance in eight out of the nine facility types. Percent Out of Compliance values for this data item ranged from 18% in seafood departments to 64% in full service restaurants.

As in the 2004 Report, this 2009 report includes a comparison between the data collected from food establishments that had a Certified Food Protection Manager (CFPM) from a program recognized by the Conference for Food Protection and those that did not. The results of the study indicate that the presence of a Certified Food Protection Manager is positively correlated to the overall IN Compliance percentages in certain facility types, especially in delis, full service restaurants, seafood departments, and produce departments. Poor Personal Hygiene, Improper Holding/Time and Temperature, and Contaminated Equipment/Protection from Contamination appear to be the risk factors for which the presence of a certified manager had the most positive correlation.

The 2003 and 2008 data collection efforts included several supplemental data items that were not included in the 1998 data collection. While original 42 data items in the study remained the same from 1998 to 2008, the supplemental data items addressed changes made to the FDA Food Code since 1997. These items related to the cooking temperature for pork, the minimum hot holding temperatures, employee health, juice, eggs, and highly susceptible populations. Data gathered for the supplemental data items suggest that reducing the minimum hot holding temperature for PHF/TCS foods from 140^oF (60ºC) to 135^oF (57ºC) and reducing the minimum cooking temperature for pork from 155^oF (68ºC) to 145^oF (63ºC) had minimal effect on the industry’s control of these risk factors.

Results from the 2008 data collection indicate that the recommendations made to foodservice and retail food operators and regulators in the 2000 and 2004 Reports need to be reemphasized. Foodservice and retail food store operators must ensure that their management systems are designed to achieve active managerial control over the risk factors. Likewise, regulators must ensure that their inspection, education, and enforcement efforts are geared toward the control of the risk factors commonly found to be Out of Compliance.

   
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